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Notice2026-03042

Request for Information: 340B Rebate Model Pilot Program

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Published
February 17, 2026

Issuing agencies

Health and Human Services DepartmentHealth Resources and Services Administration

Abstract

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHS Act), referred to as the "340B Drug Pricing Program" or the "340B Program." HRSA is issuing this Request for Information (RFI) to gather input from interested parties regarding the potential use of rebates to effectuate the ceiling price under the 340B Program, including the standards and procedures that should govern the approval of manufacturer rebate plans and the impacts on all stakeholders. This RFI seeks comments on whether HRSA should implement a rebate model under the 340B Program and how best to operationalize any such rebate framework for stakeholders. The information collected through this RFI will assist HRSA in evaluating the operational, financial, and access to drugs for patients of a rebate model on covered entities, manufacturers, and other stakeholders across the drug supply chain.

Full Text

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<title>Federal Register, Volume 91 Issue 31 (Tuesday, February 17, 2026)</title>
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[Federal Register Volume 91, Number 31 (Tuesday, February 17, 2026)]
[Notices]
[Pages 7287-7291]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03042]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Request for Information: 340B Rebate Model Pilot Program

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice, request for Information.

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SUMMARY: The Health Resources and Services Administration (HRSA) 
administers section 340B of the Public Health Service Act (PHS Act), 
referred to as the ``340B Drug Pricing Program'' or the ``340B 
Program.'' HRSA is issuing this Request for Information (RFI) to gather 
input from interested parties regarding the potential use of rebates to 
effectuate the ceiling price under the 340B Program, including the 
standards and procedures that should govern the approval of 
manufacturer rebate plans and the impacts on all stakeholders.
    This RFI seeks comments on whether HRSA should implement a rebate 
model under the 340B Program and how best to operationalize any such 
rebate framework for stakeholders. The information collected through 
this RFI will assist HRSA in evaluating the operational, financial, and 
access to drugs for patients of a rebate model on covered entities, 
manufacturers, and other stakeholders across the drug supply chain.

DATES: Comments on this notice should be received no later than March 
19, 2026.

ADDRESSES: Electronic comments should be submitted through the Federal 
eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the 
instructions on the website for submitting comments. Include the HHS 
Docket No. HRSA-2026-03042 in your comments. All comments received will 
be posted without change to: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Please do not 
include any personally identifiable or confidential business 
information you

[[Page 7288]]

do not want publicly disclosed. Any proprietary information on comments 
will not be publicly posted.
    We encourage commenters to include supporting facts, research, and 
evidence in their comments. When doing so, commenters are encouraged to 
provide citations to the published materials referenced, including 
active hyperlinks. Likewise, commenters who reference materials which 
have not been published are encouraged to upload relevant data 
collection instruments, data sets, and detailed findings as a part of 
their comment. Providing such citations and documentation will assist 
us in analyzing the comments.

FOR FURTHER INFORMATION CONTACT: Chantelle Britton, Director, Office of 
Pharmacy Affairs (OPA), Office of Special Health Initiatives, HRSA, 
5600 Fishers Lane, Mail Stop 10W29, Rockville, MD 20857; email: 
<a href="/cdn-cgi/l/email-protection#99aaada9dbe9ebf0faf0f7fed9f1ebeaf8b7fef6ef"><span class="__cf_email__" data-cfemail="ccfff8fc8ebcbea5afa5a2ab8ca4bebfade2aba3ba">[email&#160;protected]</span></a>; telephone: 301-594-4353.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 340B of the PHS Act entitled ``Limitation on Prices of 
Drugs Purchased by Covered Entities,'' was created under section 602 of 
Public Law 102-585, the ``Veterans Health Care Act of 1992,'' and 
codified at 42 U.S.C. 256b. The 340B Program is intended to enable 
covered entities ``to stretch scarce Federal resources as far as 
possible, reaching more eligible patients and providing more 
comprehensive services.'' H.R. Rep. No. 102-384(II), at 12 (1992). The 
Secretary of Health and Human Services (Secretary) has delegated the 
authority to administer the 340B Program to the HRSA Administrator, who 
in turn delegated this authority to the Office of Pharmacy Affairs, 
within HRSA, which oversees the 340B Program. Eligible covered entity 
types are defined in section 340B(a)(4) of the PHS Act, as amended. 
Section 340B(a)(1) of the PHS Act instructs HHS to enter into 
pharmaceutical pricing agreements \i\ with manufacturers of covered 
outpatient drugs. Currently, there are approximately 14,000 covered 
entities participating in the Program and 800 drug manufacturers. In 
2024 covered entities purchased $81.4 Billion of covered outpatient 
drugs under the Program. Under section 1927(a)(5)(A) of the Social 
Security Act, a manufacturer must enter into an agreement with the 
Secretary that complies with section 340B of the PHS Act ``[i]n order 
for payment to be available under section 1903(a) or under part B of 
title XVIII of the Social Security Act for covered outpatient drugs of 
a manufacturer.'' When a drug manufacturer signs a pharmaceutical 
pricing agreement, it agrees that the prices charged for covered 
outpatient drugs to covered entities will not exceed statutorily 
defined 340B ceiling prices. 340B ceiling prices are based on quarterly 
pricing reports that manufacturers provide to the Secretary through the 
Centers for Medicare & Medicaid Services (CMS) and are calculated and 
verified by HRSA.
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    \i\ OMB Number: 0915-0327
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    In 2024, HRSA began receiving inquiries directly from manufacturers 
seeking to unilaterally implement different proposed rebate models for 
the 340B Program, which manufacturers stated was, primarily to limit 
the availability to maximum fair price (MFP) to 340B covered entities 
consistent with the nonduplication provision of the Medicare Drug Price 
Negotiation Program \ii\ (MDPNP) and to facilitate other aims such as 
the prevention of 340B-Medicaid duplicate discounts and diversion. 
While the manufacturers' different proposals varied in terms of their 
scope and how they would be operationalized, the proposals all required 
that, under a rebate model, a covered entity would order the drug at a 
higher price and would then receive a rebate that reflects the 
difference between that higher initial price and the discounted 340B 
price, a departure from the way that the 340B Program has traditionally 
operated as an up-front discount program (i.e., a covered entity 
receives the discounted 340B price at the time of purchase).
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    \ii\ Maximum Fair Price refers to the negotiated price under the 
Medicare Drug Price Negotiation Program (Negotiation Program). See 
42 U.S.C. 1320f(c)(2). Under the MDPNP ``nonduplication'' provision, 
manufacturers that agree to a maximum fair price are not required to 
provide a covered entity access to the negotiated maximum fair price 
under that agreement if the drug is also subject to a 340B agreement 
and the 340B ceiling price is lower than the maximum fair price. 42 
U.S.C. 1320f-2(d).
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    Section 340B(a)(1) of the PHS Act states, ``[t]he Secretary shall 
enter into an agreement with each manufacturer of covered outpatient 
drugs under which the amount required to be paid (taking into account 
any rebate or discount, as provided by the Secretary) to the 
manufacturer for [certain] covered outpatient drugs . . . purchased by 
a covered entity . . . does not exceed [designated prices].'' In 
response to manufacturers' inquiries, HRSA made clear that implementing 
a rebate model proposal without prior Secretarial approval would 
violate section 340B(a)(1) of the PHS Act.
    In light of the significant feedback received both from 
manufacturers and covered entities, and Congressional concern regarding 
the shift from an upfront discount to a rebate model, HRSA became 
interested in testing the merits and shortcomings of a rebate model, 
including whether it would be beneficial to manufacturers participating 
in the MDPNP as well as to 340B program integrity efforts relating to 
the prevention of 340B Medicaid duplicate discounts and diversion. HRSA 
sought a balanced and measured approach to allow eligible manufacturers 
to implement rebate models, at the Secretary's direction and 
discretion, within certain parameters that would cause minimal impact 
on 340B covered entities.
    Therefore, on August 1, 2025, HRSA published a Federal Register 
notice titled ``340B Program Notice: Application Process for the 340B 
Rebate Model Pilot Program,'' 90 FR 36,163 (August 1, 2025). 
Recognizing that a rebate model would shift how the 340B Program has 
operated for over 30 years, HRSA invited manufacturers that met 
specific criteria to voluntarily participate in the 340B Rebate Model 
Pilot Program. A technical correction extended the public comment 
period to September 8, 2025, 90 FR 38,165 (August 7, 2025). HRSA 
received 1,243 public comments from stakeholders, including covered 
entity and manufacturer trade organizations, individual covered 
entities, and pharmaceutical manufacturers.
    Covered entities filed suit on December 1, 2025, to enjoin 
implementation of the rebate pilot. In accordance with the December 29, 
2025, order of the U.S. District Court for the District of Maine in 
American Hospital Association et al. v. Kennedy et al., No. 25-cv-600 
(D. Me.), HRSA paused implementation of the 340B Rebate Model Pilot 
Program for all covered entities and the nine manufacturers approved to 
participate in the pilot.
    HRSA is now requesting comments from stakeholders to further 
evaluate the potential benefits and costs of a rebate model, among 
other topics. HRSA is issuing this RFI to seek comments from 
stakeholders across the continuum of the drug supply chain in order to 
gather information on how a rebate model would impact covered entities, 
manufacturers, wholesalers, State Medicaid Agencies, pharmacies, the 
Federal Government, and other stakeholder groups. By issuing this RFI, 
HRSA is undertaking a methodical and deliberate approach to assess 
whether to implement a potential 340B Rebate Model Pilot Program 
consistent with its

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statutory authority. Likewise, HRSA commits to analyzing the comments 
received prior to pursuing the implementation of a potential 340B 
Rebate Model Pilot Program.
    HRSA is inviting comments on a range of issues, including:
    <bullet> administrative, operational, financial, and medication 
access concerns in connection with rebate models;
    <bullet> reliance interests in continuing to obtain the 340B 
ceiling prices through upfront discounts and whether such reliance 
interests are reasonable in light of the Secretary's express statutory 
authority to provide for discounts via ``rebate or discount;''
    <bullet> potential cash-flow impacts; and
    <bullet> proposed alternatives and scope-limiting measures to 
inform a rebate pilot design, including safeguards to promote the 
integrity of the 340B Program, and avoid duplicate discounts, as well 
as consistency with the MDPNP nonduplication provision.
    In addition, HRSA seeks input on how to:
    <bullet> appropriately balance stakeholder concerns regarding 
implementation of a rebate model against the agency's goal of testing 
rebates in the 340B Program;
    <bullet> gather empirical data on the effectuation of the ceiling 
price through use of rebates;
    <bullet> generate data relevant to other Federal health care 
programs, including the MDPNP; and
    <bullet> improve transparency and inform future policy decisions.
    With the information collected from this RFI, HRSA will evaluate if 
a potential 340B Rebate Model Pilot Program is in the public's interest 
and, if so, determine a viable implementation strategy, consistent with 
the 340B statute.

II. Request for Comments

    The purpose of this RFI is to obtain information and public 
comments on the standards and procedures by which HRSA should consider 
implementation of a rebate model under the 340B Program. All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on 
that website to view public comments. HRSA will not post on 
<a href="http://Regulations.gov">Regulations.gov</a> public comments that make threats to individuals or 
institutions or suggest that the individual will take actions to harm 
the individual. HRSA continues to encourage individuals not to submit 
duplicative comments. We will post acceptable comments from multiple 
unique commenters even if the content is identical or nearly identical 
to other comments.
    HRSA is seeking input to ensure that it considers all aspects of 
the problem and to ensure a fair and transparent comment process for 
all stakeholders. HRSA invites comments on all aspects of a rebate 
pilot program implementation under the 340B Program, but specifically 
seeks comments on the targeted areas below:

1. Costs to Covered Entities

a. Current Administrative Costs Under the Upfront 340B Discount
    i. Provide the total number of 340B transactions processed by your 
organization during the most recent fiscal year.
    ii. Describe your current administrative costs, including costs to 
third parties (e.g., contract pharmacies) related to 340B Program 
operations and compliance.
    iii. Identify any key cost drivers (e.g., staffing, IT systems, 
third-party vendors, compliance activities, labor hours) for current 
administrative costs.
b. Administrative Costs Under a Potential 340B Rebate Model Pilot 
Program
    i. Estimate the incremental administrative and operational costs 
your organization would incur under a 340B Model Rebate Pilot Program, 
distinguishing between one-time startup costs and ongoing costs. These 
figures can be measured in terms of hours to complete the activities or 
in dollar amounts in the aggregate. In addition, the estimation can 
include administrative and operational costs associated with filing 
rebate requests for the drugs selected for MFP under MDPNP.
    ii. Describe the methodology and assumptions used to develop these 
estimates.
    iii. Specify the activities or functions these incremental costs 
would cover (e.g., claims processing, data submission, reconciliation, 
audit support) and what, if any, effect the change of some drugs to a 
rebate model would have on current administrative costs under the 
upfront 340B discount.
    iv. If a potential 340B Rebate Model Pilot Program were structured 
so as to offset these administrative and operational costs, how could 
that be achieved and how could such an offset be accurately quantified?
    v. Comment on the impact of these incremental costs under your 
current operations.
c. Staffing Impacts Under a Potential 340B Rebate Model Pilot Program
    i. Indicate whether implementation of a potential 340B Rebate Model 
Pilot Program would require additional full-time employees or would 
cause current medical provider full-time employees to reallocate work 
hours from medical care to perform administrative functions 
(quantifying wherever possible).
    ii. If yes, identify the anticipated number of additional full-time 
employees; describe their roles, responsibilities, and functions; and 
indicate whether the FTEs would be temporary or permanent.
d. Systems and Infrastructure for Implementation of a Potential 340B 
Rebate Model Pilot Program
    i. Describe any new or modified IT systems, software, or data 
infrastructure that would be required to implement a potential 340B 
Rebate Model Pilot Program.
    ii. Provide estimated costs for system development, procurement, 
maintenance, or integration that would be required to implement a 
potential 340B Rebate Model Pilot Program and specify whether any such 
costs would be one-time or recurring.
e. Other Anticipated Costs or Impacts of a Potential 340B Rebate Model 
Pilot Program
    i. Discretely identify any additional costs to your organization 
associated with implementation of a potential 340B Rebate Model Pilot 
Program not otherwise captured above (e.g., legal review, training, 
consulting services, reduction in services offered, and specify whether 
these costs are one-time or recurring.
    ii. Identify any organization-specific factors that could impact 
your organization's ability to participate in a potential 340B Rebate 
Model Pilot Program (e.g., rural, small business, community health 
center).
    iii. Identify any specific impacts on access to drugs for patients 
that may occur as a result of a potential 340B Rebate Model Pilot 
Program.

2. Payment Timing and Potential Cash Flow Impacts for Covered Entities

    a. Describe with specificity whether payment timing (e.g., within 
ten calendar days of submission of a complete claim) under a potential 
340B Rebate Model Pilot Program would

[[Page 7290]]

affect your cash flow, including any financial risks to your 
organization.
    b. Describe the typical payment terms under your current wholesaler 
contracts for 340B drugs, including the number of days allowed for 
payment, and whether those payment terms differ for non-340B drugs.
    i. Identify any prompt payment incentives or discounts currently 
offered by drug wholesalers for early payment and the timeframes 
associated with those incentives.
    ii. State the average number of calendar days within which your 
organization typically remits payment under these contracts.
    c. Describe with specificity whether a rebate-based payment model 
would alter payment timing compared to current drug wholesaler 
arrangements, and indicate whether alternative payment arrangements 
could mitigate any potential impacts of such a rebate-based payment.
    d. A potential 340B Rebate Model Pilot Program could require that 
all rebates be paid to the covered entity (or denied, with 
documentation in support) within 10 calendar days of data submission. 
Describe ways that a potential 340B Rebate Model Pilot Program could be 
structured to ensure that manufacturers adhere to such a requirement.
    e. Describe other ways that a potential 340B Rebate Model Pilot 
Program could be structured to address payment timing and potential 
cashflow impacts for covered entities.

3. Rebate Denials

    a. Under a potential 340B Rebate Model Pilot Program the acceptable 
grounds for a manufacturer denial of a covered entity rebate request 
could be limited (for example, limited to denials where a 340B rebate 
was provided to another covered entity on the same claim) and the 
manufacturer could be required to provide the covered entity with the 
rationale and specific documentation for reasons claims are denied. 
Explain whether your organization believes more specific guardrails 
should be built into a potential 340B Rebate Model Pilot Program to 
ensure that denials are limited to appropriate circumstances.
    b. Describe what (if any) standard process elements should be 
required for rebate denials under a potential 340B Rebate Model Pilot 
Program, including template forms and timeline for adjudications of 
improper denials.

4. Data Collection by Covered Entities

    a. Describe how your organization currently collects, maintains, 
and retains data related to 340B Program participation, including 
whether third-party vendors are used to carry out some or all of these 
activities.
    b. Identify current measures to ensure data accuracy, completeness, 
and consistency (e.g., validation checks, reconciliations, audits).
    c. Describe whether a potential 340B Rebate Model Pilot Program 
would change current data collection activities and whether any such 
changes would be one-time or ongoing.
    d. Describe the specific pharmacy and medical claims data elements 
that should comprise a potential 340B Rebate Model Pilot Program (at 
both contract pharmacies and in-house pharmacies); whether such data 
elements are currently available or are readily available; the 
source(s) for such data; and whether such data is already being 
furnished to existing third parties.
    e. Provide any recommendations for ensuring a potential 340B Rebate 
Model Pilot Program has the appropriate guardrails in place to mitigate 
any privacy and security concerns related to patient information and 
data submission, including any agreements that may be required by third 
parties.
5. Manufacturer Efforts to Avoid Duplicate Discounts
    a. Describe your organization's practices and procedures prior to 
January 1, 2026, to avoid paying both 340B discounts and Medicaid 
rebates on the same drug dispense, including data collection and 
record-maintenance practices.
    b. Describe any operational or administrative changes implemented 
by your organization since January 1, 2026, to avoid paying 340B 
discounts on drug dispenses subject to a MFP under the MDPNP, including 
any changes to data collection or record-maintenance practices.
    c. Describe your organization's experience since January 1, 2026, 
with identifying drug dispenses to a covered entity for which your 
organization did not provide access to the MFP under the non-
duplication provisions of the MDPNP.
    d. Identify any challenges encountered (e.g., data availability, 
claim identification, timing mismatches) in identifying potential 
duplicate discounts under 340B and CMS payment programs (e.g., Medicare 
and Medicaid).
    e. Identify the minimum data elements you believe are necessary for 
a manufacturer to identify potential duplicate discounts under 340B and 
CMS payment programs and the potential for the 340B Rebate Model Pilot 
Program to be an additional or alternative source for those data 
elements.
6. Required Reporting
    a. What specific data should manufacturers be required to submit 
(and to what frequency) for HRSA's review to ensure compliance with a 
potential 340B Rebate Model Pilot Program?
    b. What specific manufacturer data should HRSA share publicly (and 
to what frequency) as a potential 340B Rebate Model Pilot Program 
progresses?
    c. What should be the frequency and duration of manufacturer data 
to support the assessment of a potential 340B Rebate Model Pilot 
Program?
7. 340B Program Integrity and Other Potential Benefits of a Rebate 
Pilot
    a. Explain whether and how a potential 340B Rebate Model Pilot 
Program would affect the integrity of the 340B program.
    b. Explain whether a rebate-based model would:
    i. Assist manufacturers in their efforts to avoid paying duplicate 
discounts under 340B and CMS payment programs;
    ii. Reduce diversion or improper claims; and
    iii. Increase pricing transparency across stakeholders.
    c. Provide any recommendations for improving data collection and 
reporting to strengthen the 340B Program's integrity while minimizing 
administrative burden.
    d. Describe any other potential benefits (e.g., transparency, audit 
compliance) of a 340B Rebate Model Pilot Program to participants in the 
340B Program and to what extent these benefits outweigh any potential 
costs.

III. Collection of Information Requirements

    Please note, this is an RFI only. In accordance with the 
implementing regulations of the Paperwork Reduction Act of 1995 (PRA), 
specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt 
from the PRA. Facts or opinions submitted in response to general 
solicitations of comments from the public, published in the Federal 
Register or other publications, regardless of the form or format 
thereof, provided that no person is required to supply specific 
information pertaining to the commenter, other than that necessary for 
self-identification, as a condition of the agency's full consideration, 
are not generally considered information collections and therefore not 
subject to the PRA. The

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paperwork burden associated with a potential 340B Rebate Model Pilot 
program shall be accounted for under an information collection request 
submitted to OMB and approved in keeping with the PRA prior to pursuing 
the implementation of a potential 340B Rebate Model Pilot.
    This RFI is issued solely for information and planning purposes; it 
does not constitute a request for proposals, applications, proposal 
abstracts, or quotations. This RFI does not commit the U.S. Government 
to contract for any supplies or services or make a grant award. 
Further, HRSA is not seeking proposals through this RFI and will not 
accept unsolicited proposals. Respondents are advised that the U.S. 
Government will not pay for any information or administrative costs 
incurred in response to this RFI; all costs associated with responding 
to this RFI will be solely at the interested party's expense. In 
addition, HRSA will not respond to questions related to policy issues 
outside of the scope of a potential 340B Rebate Model Pilot Program 
raised in this RFI.
    HRSA will actively consider all input as we develop future policy. 
This RFI should not be construed as a commitment or authorization to 
incur cost for which reimbursement would be required or sought. All 
submissions become U.S. Government property and will not be returned. 
In addition, HRSA shall publicly post the public comments received in 
their entirety.

Thomas J. Engels,
Administrator.
[FR Doc. 2026-03042 Filed 2-13-26; 8:45 am]
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